Amryt Announces Positive Long-Term Safety and Efficacy Data confirming the role for Mycapssa® (oral octreotide) in the management of Acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide
- Acromegaly patients were exposed to Mycapssa® during the global Open-Label Extension (OLE) of the MPOWERED Phase 3 Trial for a maximum of 3.5 years. - Patients switching from injectable Somatostatin Receptor Ligands (iSRLs) to Mycapssa® during the OLE reported improved acromegaly symptom control on Mycapssa®. 47% reported very good or excellent symptomatic control at the end of the Randomized Control Treatment (RCT) phase when treated with iSRLs, increasing to 79% at the end of the OLE when treated with Mycapssa®. - In addition, patients switching to Mycapssa® reported an improvement in treatment satisfaction and convenience that was statistically significant. - The study demonstrated that patients maintained their long-term biochemical response with 94%, 90% and 93% of patients maintaining response at year 1, 2 and 3 of the open-label extension respectively. - IGF-1 levels were stably maintained within normal limits at the end of the OLE period (median IGF-1 levels at Baseline and at the end of the OLE were 0.82 and 0.83 respectively). - Patients in the OLE demonstrated a median compliance rate of 99%. - The long-term safety profile of Mycapssa® during the OLE was consistent with that observed in prior studies.
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